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NCT05614739Phase 1Recruiting

FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3

Study Summary

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer. Vepugratinib may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Study participation could last up to approximately 6 years, depending on which part of the study you join.

View on ClinicalTrials.gov ↗
Study Details
Enrollment677 participants
Primary Completion2027-06
Lead SponsorEli Lilly and Company
Data Retrieved2026-10-14
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Primary completion: 2027-06
Enrolled: 677 participants
Sponsor Catalyst Profile

Eli Lilly and Company (LLY) is the sponsoring company for this trial. BiotechSign currently grades this company C (51/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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